MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT PING METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4302765

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Type  Injury  

Event Description

On (b)(6) 2018, the reporter contacted lifescan (lfs) usa alleging that the patient¿s onetouch ping meter read inaccurately high compared to another device.The complaint was classified based on the customer care advocate (cca) documentation.The reporter stated that the alleged product issue first occurred on an unspecified date during the first week of (b)(6) 2018.The specific results reported were obtained on (b)(6) 2018.At this time, the patient obtained a blood glucose result of ¿593mg/dl¿ with the subject meter and ¿142mg/dl¿ on another device within 30 minutes of one another.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The reporter stated that the patient manages their diabetes with insulin pump therapy and due to the alleged product issue had been taking an increased dosage of insulin (exact dose unspecified) for a couple of weeks.The reporter did not realise the alleged product issue had occurred until the evening of (b)(6) 2018 when the patient was found ¿unconscious and unresponsive¿.The emergency medical services (ems) were called and when they arrived they measured the patient¿s blood glucose and obtained results of ¿51 and 28mg/dl¿.The patient was given glucose injections by the ems and taken to hospital where the alleged inaccurately high result of ¿593mg/dl¿ was obtained with the subject meter.No additional treatment was noted.At the time of troubleshooting, the cca noted that the unit of measure was set correctly on the subject meter.The cca walked the patient through a control solution test and it fell within the control range.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.

• Brand Name: OT PING METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7474937
• MDR Text Key: 106954378
• Report Number: 3008382007-2018-01311
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4302765
• Other Device ID Number: 1-NQGOP7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2018
• Device Age: 13 MO
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 79